FDA Recall D-0151-2024
Insight Pharmaceuticals Corporation · Langhorne, PA
Class I — life-threatening Completed 904 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET WT 4.5 oz (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591, UPC 363736532611.
Reason for recall
Chemical Contamination; presence of benzene.
Recall record
- Recall number
D-0151-2024- Classification
- Class I
- Status
- Completed
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide and Puerto Rico
- Recall initiated
- 2023-11-22
- Classified by FDA Center
- 2023-12-15
- FDA published
- 2023-12-27
- Recalling firm
- Insight Pharmaceuticals Corporation
- Firm location
- Langhorne, PA